berkley and jensen sleep aid
- Product NDC
- 68391-441
- 11-digit product format
- 683910441
- Labeler code
- 68391
- Product ID
- 68391-441_6aed4ba1-211a-4e76-bc4c-0ca3a57fb66a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Doxylamine succinate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- BJWC
- Application
- ANDA040167
- Marketing category
- ANDA
- Marketing start
- 2018-08-06
- Substance
- DOXYLAMINE SUCCINATE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- berkley and jensen sleep aid
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXYLAMINE SUCCINATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V9BI9B5YI2 |
| Rxcui | 1101446 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68391-441-02 | berkley and jensen sleep aid | 2 in 1 CARTON | TABLET | 2 | | 3 |
| 68391-441-02 | berkley and jensen sleep aid | 96 in 1 BOTTLE | TABLET | 96 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68391-441 | BERKLEY AND JENSEN SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [BJWC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250406_25f468a9-71d4-40f2-97bb-1c3ff5d4b728.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68391-441-02 | 68391044102 | 2 BOTTLE in 1 CARTON (68391-441-02) / 96 TABLET in 1 BOTTLE | 2 bottle | 2018-08-06 | No | No | Historical |